UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062819 |
|---|---|
| Receipt number | R000071793 |
| Scientific Title | The Relationship Between Patient Anxiety and Irradiation Position Deviation in Particle Therapy |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/07 09:56:53 |
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Basic information
Public title
The Relationship Between Patient Anxiety and Irradiation Position Deviation in Particle Therapy
Acronym
The Relationship Between Patient Anxiety and Irradiation Position Deviation in Particle Therapy
Scientific Title
The Relationship Between Patient Anxiety and Irradiation Position Deviation in Particle Therapy
Scientific Title:Acronym
The Relationship Between Patient Anxiety and Irradiation Position Deviation in Particle Therapy
Region
| Japan |
Condition
Condition
Prostate Cancer, Liver Cancer, Lung Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the relationship between anxiety levels measured at different stages of the heavy-ion radiation therapy process-namely, at the time of providing informed consent for the study, before the CT scan for treatment planning, before the first treatment and before the final treatment-and setup errors during treatment.
Basic objectives2
Others
Basic objectives -Others
Relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between objective measures of anxiety, such as STAI scores, respiratory rate and heart rate, and setup errors.
Key secondary outcomes
Correlation between objective measures of anxiety, such as STAI scores, respiratory rate and heart rate, and positioning time.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or over with prostate, lung or liver cancer, who are due to undergo gold marker implantation in preparation for heavy-ion beam therapy.
2. Individuals capable of completing psychological assessments.
3. Individuals from whom written informed consent can be obtained.
Key exclusion criteria
1. Patients aged 18 or over with prostate, lung or liver cancer, who are due to have gold markers inserted in preparation for heavy-ion beam therapy.
2. Individuals capable of completing psychological assessments.
3. Individuals from whom written informed consent can be obtained.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | ARATA |
| Middle name | |
| Last name | KUBOTA |
Organization
National Research and Development Agency for Quantum Science and Technology QST Hospital
Division name
Nursing Department
Zip code
263-8555
Address
4-9-1 Anagawa, Inage Ward, Chiba City, Chiba Prefecture
TEL
043-206-3306
kubota.arata@qst.go.jp
Public contact
Name of contact person
| 1st name | ARATA |
| Middle name | |
| Last name | KUBOTA |
Organization
National Research and Development Agency for Quantum Science and Technology QST Hospital
Division name
Nursing Department
Zip code
263-8555
Address
4-9-1 Anagawa, Inage Ward, Chiba City, Chiba Prefecture
TEL
043-206-3306
Homepage URL
kubota.arata@qst.go.jp
Sponsor or person
Institute
National Research and Development Agency for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Research and Development Agency for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel
043-206-4706
helsinki@qst.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2046 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Basic information on the study participants, such as age, gender, medical history, comorbidities, inpatient or outpatient status, medications, frequency of urination and bowel movements, BMI and whether pre-CT scan preparations such as enemas or flatus removal were performed, will be collected from the electronic medical record system.
Data collection on patient anxiety levels
After obtaining informed consent, the psychological test 'STAI (State-Trait Anxiety Inventory)' will be administered and respiratory and heart rates will be measured to establish baseline data.
STAI Trait Anxiety (a relatively stable anxiety tendency deeply rooted in the individual, similar to personality) is measured only once at baseline. STAI State Anxiety (anxiety that varies depending on the situation or time, reflecting anxiety in the present moment) is measured four times: at baseline, before the treatment planning CT scan, before the first treatment session and before the final treatment session.
A pulse oximeter will be used to measure respiratory rate and heart rate not only at baseline, but also prior to treatment on each irradiation day during the treatment planning CT and heavy-ion therapy periods (when the patient is lying on the treatment table and the immobilisation device is in place).
Data collection on setup errors
The amount of gold marker displacement is measured using DRR images and fluoroscopic images taken during treatment. The time required for positioning will be measured as the duration from the start to completion of positioning during heavy-ion therapy.
Data analysis
Based on the obtained data, we will verify the correlation between patient anxiety, positioning time and the amount of gold marker displacement.
Management information
Registered date
| 2026 | Year | 09 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071793
